efficacy and safety of zoval (sofosbuvir) and ribavirin with or without interferon

Conditions: Hepatitis C, Chronic

Summary: title efficacy and safety of zoval (sofosbuvir) and ribavirin with or without interferon among pakistani population: a real life trial hepatitis eradication accuracy trial of sofosbuvir (heats) study design endpoint classification: safety/efficacy study intervention model: treatment agents (non-interventional observational study): real life clinical practice study masking: open label primary purpose: treatment duration around 12 months study centre multi centric study

indication chronic hepatitis c virus (hcv) infection (serum hcv rna level, \>10,000 iu per milliliter) with or without cirrhosis primary objective o proportion of participants with sustained virologic response 12/24 weeks after discontinuation of therapy (svr 12 or 24 weeks) \[ time frame: post-treatment week 12/24 \] \[ designated as safety issue: no \] svr 12/24 is defined as hcv rna \< the lower limit of quantification (lloq; ie, \< 15 iu/ml) 12/24 weeks following the last dose of study medication. secondary objective o proportion of participants experiencing viral breakthrough \[ time frame: up to 12 or 24 weeks \] \[ designated as safety issue: no \] viral breakthrough is defined as hcv rna ≥ lower limit of quantification (lloq) after having previously had hcv rna \< lloq while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be post treatment), or last available on-treatment measurement with no subsequent follow-up values. * proportion of participants experiencing viral relapse \[ time frame: up to post treatment week 12 or 24 \] \[ designated as safety issue: no \] viral relapse is defined as hcv rna ≥ lloq during the post-treatment period having achieved hcv rna \< lloq at end of treatment, confirmed with 2 consecutive values or last available post treatment measurement. * proportion of participants with early virological response 4 weeks after start of therapy (evr4) \[ time frame: treatment week 4 \] \[ designated as safety issue: no \] * svr 12/24 is defined as hcv rna \< the lower limit of quantification (lloq; ie, \< 15 iu/ml) 12/24 weeks following the last dose of study medication.proportion of hcv rna within 12 or 24 weeks change from baseline in hcv rna (log10 iu/ml) \[ time frame: up to 12 or 24 weeks \] \[ designated as safety issue: no \] * proportion of participants experiencing an adverse event (ae) leading to permanent discontinuation of study medication \[ time frame: baseline to week 12 or 24 \] \[ designated as safety issue: no \] number of subjects 5000 patients dosing - sofosbuvir 400 mg tablet taken once daily orally * ribavirin twice daily orally * 1000 mg in patients with body weights \<75 kg * 1200 mg in those with weights \>75 kg * interferon for 12 or 24 weeks drug duration duration and combination depends upon the discretion of principal investigator. proposed duration for genotype: inclusion criteria • men and women, 18 years of age or older, * treatment -naïve and not responded with the previous therapy * hcv relapse * patient of hcv waiting for transplant, bridge to transplant * cirrhosis * not previously enrolled in any trial/study of sofosbuvir exclusion criteria o not given informed consent o pregnancy

Eligibility criteria:
inclusion criteria: * men and women, 18 years of age or older, * treatment -naïve and not responded with the previous therapy * cirrhosis * not previously enrolled in any trial of sofosbuvir exclusion criteria: * not given informed consent * pregnancy

Keywords: hcv safety efficacy evr svr